Sec. 24. An individual or entity that is an operator shall comply with the following training responsibilities:

(1) Ensure that the training described in the Indiana Occupational Safety and Health Administration's bloodborne pathogens standard (as found in 29 CFR 1910.1030) is provided to all tattoo artists and body piercers, anyone employed by the facility or anyone acting on behalf of the facility, who has a reasonably anticipated risk for skin, eye, mucous membrane, or parenteral contact with blood or OPIM.

(2) Ensure that training on the handling of infectious waste is provided to all tattoo artists and body piercers, or anyone employed by the facility or anyone acting on behalf of the facility who has a reasonably anticipated risk for skin, eye, mucous membrane, or parenteral contact with blood or OPIM.

(3) Ensure that a record of training described in subdivision (1) is maintained, as required under the Indiana Occupational Safety and Health Administration's bloodborne pathogens standard (as found in 29 CFR 1910.1030) of an individual's participation in the training that is provided. The record shall be made available to the department for inspection upon request.

(4) Ensure that a record of training described in subdivision (2) is maintained.

410 IAC 1-5-24 Operator training responsibilities

Requires the operator to ensure that all persons working at the parlor who have a "reasonably anticipated risk" of exposure to blood receive bloodborne pathogen training in accordance with the OSHA bloodborne pathogen standard. Persons working at the facility who need training would include, but may not be limited to, tattoo artists, body piercers, and persons who clean areas that are contaminated with blood. OSHA requires yearly training.

Training on handling of infectious waste would include training on the infectious waste policies of the facility. Those policies should be consistent with the requirements of this rule.

410 IAC 1-5-25 Operator responsibilities

Sec. 25.

(a) The operator shall ensure that tattoo artists, body piercers, or anyone employed by the facility or anyone acting on behalf of the facility who has a reasonably anticipated risk for skin, eye, mucous membrane, or parenteral contact with blood have and use personal protective equipment and expendables needed to implement the precautions required by this rule and the Indiana Occupational Safety and Health Administration's bloodborne pathogens standard (as found in 29 CFR 1910.1030).

(b) The operator shall require tattoo artists and body piercers, anyone employed by the facility, or anyone acting on behalf of the facility who has a reasonably anticipated risk for skin, eye, mucous membrane, or parenteral contact with blood to provide evidence of compliance with the universal/standard precautions education requirements contained in section 27 of this rule.

(c) The operator shall display a description of compliance with the requirements contained in subsection (d).

(d) The operator shall display written materials prepared or approved by the department explaining universal precautions and patrons' rights under this rule. These materials shall include information on how to report violations of universal precautions and shall include information regarding the department's duties to investigate.

410 IAC 1-5-25 Operator responsibilities

The operator ensures that the necessary equipment to implement the precautions listed in the rule is available to all those employed by the operator.

ISDH-prepared Patrons' Rights information or equivalent information approved by ISDH must be displayed.

410 IAC 1-5-26 Operator policies

Sec. 26. The operator shall develop a written policy in compliance with this rule and the requirements of the Indiana Occupational Safety and Health Administration's bloodborne pathogen standard (as found in 29 CFR 1910.1030) that:

(1) requires the use of universal precautions when performing tattooing or body piercing and any activity or duty that includes any reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or OPIM;

Sec. 27. (a) All tattoo artists, body piercers, anyone employed by the facility, and anyone acting on behalf of the facility, who has a reasonably anticipated risk for skin, eye, mucous membrane, or parenteral contact with blood or OPIM shall complete the training program that is required under the requirements of the Indiana Occupational Safety and Health Administration's bloodborne pathogen standard (as found in 29 CFR 1910.1030). The programs under this section shall be as follows:

(1) A bloodborne pathogen training session provided by the operator meeting the requirements under the Indiana Occupational Safety and Health Administration's bloodborne pathogens standard (as found in 29 CFR 1910.1030).

(2) Any bloodborne pathogen continuing education program provided by a health care agency.

(b) All tattoo artists, body piercers, anyone employed by the facility, and anyone acting on behalf of the facility, who has a reasonably anticipated risk for skin, eye, mucous membrane, or parenteral contact with blood or OPIM must be trained in the facility's policies on the handling of infectious waste.

410 IAC 1-5-27 is similar to 410 IAC 1-5-24. The difference is the artist must receive the listed training, rather than the operator, ensuring that the training is completed.

The operator can provide the bloodborne pathogen training. The requirements of the trainer and the training session are found in the OSHA bloodborne pathogen standard.

Organizations such as the Red Cross and other professional groups can provide training. Also, individuals who meet the requirements for a trainer, as found in 29 CFR 1910.1030, can provide the training.

The operator needs to train staff on the handling of infectious waste in the facility, such as storage and treatment of the infectious waste prior to final disposal.

410 IAC 1-5-28 Patron records

Sec. 28. Records of each patron shall be maintained by the operator for two (2) years. The record shall include the following, but not be limited to:

(1) Patron's name.

(2) Address.

(3) Age.

(4) Date tattooed or body pierced.

(5) Design of the tattoo.

(6) Location of the tattoo or body piercing on the patron's body.

(7) The name of the tattoo artist or body piercer who performed the work.

(8) Jewelry or other decoration used.

410 IAC 1-5-28 Patron records

Patron records must be maintained for 2 years and may be reviewed by health department personnel. Reports of bloodborne pathogen disease transmission would be a reason for a record review.

410 IAC 1-5-29 Illness

Sec. 29. Tattoo artists or body piercers who are experiencing symptoms of acute disease that include, but are not limited to:

(b) Hands shall be washed with soap and running water immediately before putting on gloves and after removal of gloves or other personal protective equipment.

(c) Only single-use towels shall be used.

410 IAC 1-5-30 Handwashing

Soap and running water are required and the hand- washing facility must be readily accessible. An accessible facility is one in which the tattoo artist or body piercer would not contaminate a surface prior to washing hands.

(1) A clean protective clothing layer shall be worn whenever there is a reasonably anticipated risk of contamination of clothing by blood or OPIM.

(2) Masks in combination with eye protection devices, such as goggles or glasses with solid side shield, or chin length face shield, shall be worn whenever splashes, spray, splatter, or droplets of blood or OPIM may be generated and eye, nose, or mouth contamination can be reasonably anticipated.

(3) Disposable gloves, such as surgical or examination type, shall be worn during the tattooing or body piercing process. Gloves shall be changed and properly disposed

of each time there is an interruption in the application of the tattoo or body piercing, when the gloves become torn or punctured, or whenever the ability to function as a barrier is compromised. Disposable gloves shall not be reused.

A protective outer clothing layer is needed only when there is a risk of contaminating clothing with blood or OPIM (as defined in the OSHA Bloodborne Pathogen Standard).

Masks and/or eye protection are only needed when the tattoo artist or body piercer anticipates splashing into the eyes, mouth, or nose. Often such splashing is not anticipated.

Gloves must be of surgical or examination type.

Hands must be washed with soap and running water immediately before putting on gloves, and after removal of gloves or other personal protective equipment.

410 IAC 1-5-32 Tattooing equipment

Sec. 32. (a) Only single-use razors shall be used to shave the area to be tattooed.

(b) All stencils shall be properly disposed of after a single use.

(c) If the design is drawn directly onto the skin, it shall be applied with a single-use article only.

410 IAC 1-5-32 Tattooing equipment

Single-use razors must be used when shaving skin areas.

When stencils are used, they must be single-use and properly disposed of. Disposal can be in the regular waste as long as the stencil does not contain blood to the point that blood could be released from the stencil.

Articles used to draw designs on the skin, such as ink pens, must be single-use.

(d) Contaminated needles shall not be bent or broken or otherwise manipulated by hand.

410 IAC 1-5-33 Needles

Many needle companies do not package the needles in sterile packaging. Many companies package several needles together. If the original packaging did not provide a sterile product, the tattoo artist or body piercer must sterilize the needle prior to use.

Items being sterilized must be placed in individual packaging, unopened, so that they will be sterile at the time of use. Two or more items can be placed in the same package if they will be used at the same time.

410 IAC 1-5-34 Reusable equipment

Sec. 34. (a) Heating procedures capable of sterilization must be used when heat stable, nondisposable equipment is sterilized.

(b) Equipment that is to be sterilized shall be put in single-use packaging.

(c) Records must be maintained to document the following:

(1) Duration of sterilization technique.

(2) Determination of effective sterility, such as use of a biological indicator, is performed monthly.

(3) Equipment is maintained as recommended by the owner's manual, and proof is available that the owner's manual recommendations are reviewed monthly.

(d) Reusable contaminated equipment shall not be stored or processed in a manner that requires any person to reach by hand into the containers where these sharp items have

been placed.

(e) Reusable contaminated equipment shall be:

(1) placed in puncture-resistant containers;

(2) labeled with the biohazard symbol;

(3) leakproof on both sides and bottom; and

(4) stored in a manner that does not require reaching by

hand into the container where the equipment is stored until cleaning prior to sterilization.

(g) Any reusable contaminated equipment that comes into direct contact, or is likely to come into direct contact, with an instrument that penetrates the skin other than a piercing gun shall be effectively cleaned and sterilized prior to use.

(h) All sterilized equipment shall not be removed from wrappers or sterilizer packaging until immediately prior to use.

(i) Any reusable equipment that comes into contact with mucus [sic., mucous] membranes shall be effectively cleaned and sterilized prior to use.

(j) Piercing guns shall be cleaned and undergo, at a minimum, high level disinfection after each use and whenever visibly contaminated.

(k) All reusable equipment that has contact with intact skin shall undergo, at a minimum, intermediate level disinfection.

(l) All other equipment used during the tattooing or body piercing procedure shall be single use, including corks.

(m) All body piercers and tattoo artists shall comply with all other equipment manufacturer's recommendations.

410 IAC 1-5-34 Reusable equipment

Heating procedures used can include the use of an autoclave, Chemclave, or a dry heat sterilizer. Pressure cookers or toaster ovens cannot be used. Using a biological indicator (spore checking) is a method to assure sterility when using your autoclave, Chemclave, or dry heat sterilizer equipment.

Single-use packaging means that all equipment sterilized in the package will be used at the same time. For example, a needle and tube can be packaged together.

Biological indicators can be purchased from companies

that provide medical supplies, or may be available from local laboratories that provide this service.

Documentation of the duration of sterilization technique can be a policy and does not need to be logged for each sterilization cycle.

Any equipment that penetrates the skin (i.e. needles) or comes into direct contact with an instrument that penetrates the skin, except a piercing gun, requires sterilization. Examples of such equipment would include forceps when tongue piercing, tubes used when tattooing, and corks that touch the needle after the needle penetrates the skin.

All equipment that must be sterile MUST be placed in wrappers or sterilized packaging.

This rule does not specify how to clean the equipment prior to sterilization. Ultrasonic cleaners are often used but ultrasonic cleaning is not required.

The mouth is a mucous membrane. Thus, reusable equipment touching the mouth must be sterile.

Piercing guns must undergo, at a minimum, high level disinfection. Solutions called "chemical sterilants" are used to achieve high level disinfection (destroying all micro-organisms, with the exception of high numbers of bacterial spores). These solutions must be registered with the Environmental Protection Agency (EPA). The manufacturer of the sterilant will specify the recommended time that the piercing gun should have contact with the sterilant in order to achieve high level disinfection.

410 IAC 1-5-35 Dyes or pigments or other objects placed under the skin

Sec. 35. (a) All dyes or pigments used in tattooing shall be from professional suppliers specifically providing dyes or pigments for the tattooing of human skin.

(b) In preparing dyes or pigments to be used by tattoo artists, only nontoxic, sterile materials shall be used. Single-use or individual portions of dyes or pigments in clean, single-use containers shall be used for each patron.

(c) After tattooing, the remaining unused dye or pigment

in single-use or individual containers shall be discarded along with the container.

(d) Any object placed under the skin shall be sterile.

410 IAC 1-5-35 Dyes or pigments or other objects placed under the skin

The Food and Drug Administration does not regulate dyes and pigments.

Most single-use containers in the industry are plastic.

Objects, such as jewelry or sand or ashes placed under the skin, must be sterile.

410 IAC 1-5-36 Work environment

Sec. 36. (a) No tattooing or body piercing shall be conducted in any room used as living quarters or in any room that opens directly into living or sleeping quarters.

(b) Live animals shall be excluded from areas where tattooing or body piercing is being conducted. This exclusion does not apply to the following:

(1) Patrol dogs accompanying security or police officers.

(2) Guide dogs accompanying the following:

(A) Blind persons.

(B) Partially blind persons.

(C) Physically disabled persons.

(D) Guide dog trainers.

(E) Persons with impaired hearing.

(c) Eating, drinking, smoking, applying cosmetics, or handling contact lenses shall not be allowed in work areas where there is a likelihood of exposure to blood or OPIM.

(d) Food and drink shall not be kept in areas where there is a reasonably anticipated risk of exposure to blood or OPIM.

(e) All equipment and environmental surfaces shall be cleaned and disinfected after contact with blood or OPIM.

(f) Environmental surfaces and equipment not requiring sterilization that have been contaminated by blood shall be cleaned and disinfected.

(2) sodium hypochlorite, five-tenths percent (0.5%) concentration, by volume (common household bleach in ten percent (10%) concentration in water); the solution shall be dated and shall not be used if it is more than twenty-four (24) hours old.

Disinfectant solutions can be purchased from a supplier of medical products or may be available over-the-counter. Disinfectants that kill tuberculosis are strong enough to kill hepatitis B, hepatitis C, and HIV. The label should identify tuberculocidal solutions.

410 IAC 1-5-37 Infectious waste containment

Sec. 37. (a) Contaminated disposable needles or instruments shall be:

(1) stored in:

(A) leak-resistant; and

(B) puncture-resistant;

containers;

(2) tightly sealed to prevent expulsion;

(3) labeled with the biohazard symbol; and

(4) effectively treated in accordance with this rule prior to being stored in an unsecured area and sent for final disposal.

(b) Infectious wastes that are not contaminated sharps or objects that could potentially become contaminated sharps shall be placed in containers that meet the following requirements:

(1) Impervious to moisture.

(2) Sufficient strength and thickness to prevent expulsion.

(3) Secured to prevent leakage expulsion.

(4) Labeled with the biohazard symbol.

(5) Effectively treated in accordance with this rule prior to being placed in an unsecured area and sent for final disposal.

(c) If infectious waste is stored prior to final disposal, all persons subject to this rule shall store infectious waste in a secure area that:

(1) is locked or otherwise secured to eliminate access by or exposure to the general public;

(2) affords protection from adverse environmental conditions and vermin; and

(3) has a prominently displayed biohazard symbol.

(d) Infectious waste shall be stored in a manner that preserves the integrity of the container and is not conducive to rapid microbial growth and putrefaction.

(e) Disinfect reusable containers for infectious waste each time that they are emptied unless the surfaces of the reusable containers have been protected from contamination by disposable liners, bags, or other devices that are removed with the infectious waste.

410 IAC 1-5-37 Infectious waste containment

Containers for infectious waste may be purchased

from companies that provide medical supplies.

An example of infectious waste (other than sharps) is a gauze that releases blood when compressed. Any gauze that does not release blood when compressed IS NOT infectious waste.

410 IAC 1-5-38 Treatment and transport of infectious waste

Sec. 38. (a) All operators shall ensure that infectious waste is either treated on-site in accordance with this rule or transported off-site for treatment in accordance with this rule.

(b) A treatment is effective if it reduces the pathogenic qualities of infectious waste for safe handling, is designed for the specific waste involved, and is carried out in a manner consistent with this rule. Effective treatment may include:

(1) incineration in an incinerator designed to accommodate infectious waste;

(2) steam sterilization;

(3) chemical disinfection under circumstances where safe handling of the waste is assured;

(4) thermal inactivation;

(5) irradiation; or

(6) discharge in a sanitary sewer or septic system that is properly installed and operating in accordance with state and local laws.

(c) All persons subject to this rule shall:

(1) transport infectious waste in a manner that reasonably protects waste haulers and the public from contracting a dangerous communicable disease; and

(2) effectively treat infectious waste in accordance with this rule before it is compacted.

(d) The operator shall ensure that infectious waste, effectively treated or not is transported off-site in compliance with 410 IAC 1-3.

410 IAC 1-5-38 Treatment and transport of infectious waste

Infectious waste can be treated on-site (at the facility) as long as treatment is effective for the waste and makes the waste safe for handling. Treating the waste in an autoclave is effective. Some studies show that needles require 45-60 minutes in an autoclave to be safe for handling.

Pouring bleach over the infectious waste would not meet the requirement, since it could not be assured that the waste is safe for handling.

After on-site treatment, the container must be marked as treated infectious waste and all of the requirements in 410 IAC 1-3-28 (Infectious Waste Rule) must be met. The requirements found in 410 IAC 1-3-28 allow for either the name, address, and phone number of the generating facility and the treatment facility (waste company if used) to be enclosed between a secondary container and outer packaging (i.e. between the "sharps container" and the outside box), or the same information can be on the outside of the outermost packaging. A form with infectious waste treatment information must also be available.

Infectious waste treatment companies can provide a service to pick up the infectious waste and treat it prior to final disposal.

Incineration of infectious waste must take place in an incinerator designed for infectious waste.